000086474 001__ 86474 000086474 005__ 20230914083238.0 000086474 0247_ $$2doi$$a10.1002/cam4.2555 000086474 0248_ $$2sideral$$a115275 000086474 037__ $$aART-2019-115275 000086474 041__ $$aeng 000086474 100__ $$aPeñalver, FJ 000086474 245__ $$aResponse-adapted treatment with rituximab, bendamustine, mitoxantrone, and dexamethasone followed by rituximab maintenance in patients with relapsed or refractory follicular lymphoma after first-line immunochemotherapy: Results of the RBMDGELTAMO08 phase II trial 000086474 260__ $$c2019 000086474 5060_ $$aAccess copy available to the general public$$fUnrestricted 000086474 5203_ $$aBackground Consensus is lacking regarding the optimal salvage therapy for patients with follicular lymphoma who relapse after or are refractory to immunochemotherapy. Methods This phase II trial evaluated the efficacy and safety of response-adapted therapy with rituximab, bendamustine, mitoxantrone, and dexamethasone (RBMD) in follicular lymphoma patients who relapsed after or were refractory to first-line immunochemotherapy. Sixty patients received three treatment cycles, and depending on their response received an additional one (complete/unconfirmed complete response) or three (partial response) cycles. Patients who responded to induction received rituximab maintenance therapy for 2 years. Results Thirty-three (55%) and 42 (70%) patients achieved complete/unconfirmed complete response after three cycles and on completing induction therapy (4-6 cycles), respectively (final overall response rate, 88.3%). Median progression-free survival was 56.4 months (median follow-up, 28.3 months; 95% CI, 15.6-51.2). Overall survival was not reached. Progression-free survival did not differ between patients who received four vs six cycles (P = .6665), nor between patients who did/did not receive rituximab maintenance after first-line therapy (P = .5790). Median progression-free survival in the 10 refractory patients was 25.5 months (95% CI, 0.6-N/A) and was longer in patients who had shown progression of disease after 24 months of first-line therapy (median, 56.4 months; 95% CI, 19.8-56.4) than in those who showed early progression (median, 42.31 months; 95% CI, 24.41-NA) (P = .4258). Thirty-six (60%) patients had grade 3/4 neutropenia. Grade 3/4 febrile neutropenia and infection were recorded during induction (4/60 [6.7%] and 5/60 [8.3%] patients, respectively) and maintenance (2/43 [4.5%] and 4/43 [9.1%] patients, respectively). Conclusions This response-adapted treatment with RBMD followed by rituximab maintenance is an effective and well-tolerated salvage treatment for relapsed/refractory follicular lymphoma following first-line immunochemotherapy. 000086474 540__ $$9info:eu-repo/semantics/openAccess$$aby-nc$$uhttp://creativecommons.org/licenses/by-nc/3.0/es/ 000086474 590__ $$a3.491$$b2019 000086474 591__ $$aONCOLOGY$$b111 / 244 = 0.455$$c2019$$dQ2$$eT2 000086474 592__ $$a1.315$$b2019 000086474 593__ $$aRadiology, Nuclear Medicine and Imaging$$c2019$$dQ1 000086474 593__ $$aCancer Research$$c2019$$dQ2 000086474 593__ $$aOncology$$c2019$$dQ2 000086474 655_4 $$ainfo:eu-repo/semantics/article$$vinfo:eu-repo/semantics/publishedVersion 000086474 700__ $$aMarquez, JA 000086474 700__ $$aDuran, S 000086474 700__ $$aGiraldo, P 000086474 700__ $$aMartin, A 000086474 700__ $$aMontalban, C 000086474 700__ $$aSancho, JM 000086474 700__ $$aRamirez, MJ 000086474 700__ $$aTerol, MJ 000086474 700__ $$aCapote, FJ 000086474 700__ $$aGutierrez, A 000086474 700__ $$aSanchez, B 000086474 700__ $$aLopez, A 000086474 700__ $$aSalar, A 000086474 700__ $$aRodriguez-Caravaca, G 000086474 700__ $$aCanales, M 000086474 700__ $$aCaballero, MD 000086474 700__ $$aLopez, JLB 000086474 700__ $$aCarbonell, F 000086474 700__ $$aBordas, SF 000086474 700__ $$aLopez, PF 000086474 700__ $$aPersona, EP 000086474 700__ $$aGuillermo, AL 000086474 700__ $$aMartin, RH 000086474 700__ $$aMayans, JR 000086474 700__ $$0(orcid)0000-0001-8515-3599$$aPalomera, L$$uUniversidad de Zaragoza 000086474 700__ $$aCeballos, EP 000086474 700__ $$aHernandez, JAQ 000086474 700__ $$aGrau, RR 000086474 700__ $$ade la Cruz, F 000086474 700__ $$aSalinas, AS 000086474 7102_ $$11007$$2610$$aUniversidad de Zaragoza$$bDpto. Medicina, Psiqu. y Derm.$$cArea Medicina 000086474 773__ $$g8, 16 (2019), 6955-6966$$pCancer med.$$tCancer medicine$$x2045-7634 000086474 8564_ $$s509841$$uhttps://zaguan.unizar.es/record/86474/files/texto_completo.pdf$$yVersión publicada 000086474 8564_ $$s83005$$uhttps://zaguan.unizar.es/record/86474/files/texto_completo.jpg?subformat=icon$$xicon$$yVersión publicada 000086474 909CO $$ooai:zaguan.unizar.es:86474$$particulos$$pdriver 000086474 951__ $$a2023-09-13-10:46:52 000086474 980__ $$aARTICLE